April 20, 2022
This page describes the exemption at 45 CFR 46.104(d)(5) of the 2018 Requirements, its posting requirement, and how that requirement is being implemented at the Department of Health and Human Services (HHS). If you have questions about how the posting requirement is being implemented by another Common Rule department or agency, please contact them directly.
Regulatory Background
The revised Common Rule includes the following exemption at 45 CFR 46.104(d)(5):
Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.
The revised Common Rule also provides at 45 CFR 46.104(d)(5)(i) that:
Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.
1. What entity is responsible for fulfilling the posting requirement specified for exempt studies conducted under 45 CFR 46.104(d)(5), and where should studies be posted?
HHS anticipates that the HHS component supporting or conducting the research will be responsible for fulfilling the posting requirement on behalf of HHS. HHS has identified Regulations.gov [Docket ID: HHS-OPHS-2018-0025] as a posting site. However, posting may occur on a different publicly accessible federal site identified by the HHS component for this specific purpose, or in such other manner as the Secretary of HHS (as the department or agency head) may determine (45 CFR 46.102(c), 46.104(d)(5)(i)). The posting must identify each study conducted under this exemption (45 CFR 46.104(d)(5)(i)).
2. Can a researcher begin to conduct a study involving human subjects under 45 CFR 46.104(d)(5) prior to the posting required by section 46.104(d)(5)(i)?
No. Section 46.104(d)(5)(i) specifically states that human subjects cannot be involved in a study prior to that posting. Accordingly, once the federal agency supporting or conducting the research determines that application of this exemption would be appropriate with regard to a particular study, the study must be posted on a publicly accessible federal website (or in such other manner as the department or agency head may determine) before the researcher begins any portion of the study involving human subjects.
HHS anticipates that the HHS component supporting or conducting the research will determine whether application of this exemption would be appropriate. Note that OHRP retains oversight authority regarding whether a study qualifies for the exemption provided at 45 CFR 46.104(d)(5).
